UNCAGED BRIEFING, JANUARY 2007

The Ombudsman's Report on Home Office Regulation of Imutran
Xenotransplantation Research: the Need for a Public Administration
Select Committee Inquiry

Summary

On 15 December 2006, the Parliamentary and Health Service Ombudsman
(PHSO) laid before Parliament a report (PA-2823) that dismissed
Uncaged's complaint of maladministration in respect of the
Home Office's regulation of Imutran's pig-to-primate
xenotransplantation research (1994-2000). (1)

As we explain below, we believe that the PHSO's investigation
and report are fundamentally flawed. We submit that the PHSO's
investigation has been opaque, ambiguous and partial, and their
report fails to reach coherent, evidence-based judgements. Of particular
concern are the several instances where primates were found dead
or in a collapsed state in procedures assessed as of merely 'moderate' severity.
Thus, in exonerating the Home Office, the PHSO's has failed
to hold the department to account for its failure to properly assess
and minimise the suffering of animals.

Animal experimentation raises major ethical and social concerns,
and is a matter of significant public interest. It is vital that
the public has genuine confidence in the impartiality of regulators
and the rule of law. We are therefore seeking an investigation
into the PHSO report by the Public Administration Select Committee.

The author of this briefing, Dr Dan Lyons has recently been awarded
a PhD for his research into the evolution of animal research policy,
thereby establishing him as one of Britain's leading academic
authorities on this area of public policy.

Background

In spring 2000, confidential documents relating to pig-to-primate
organ transplants were leaked from the company responsible, Imutran.
Our analysis of the data led us to believe that not only had Imutran
breached the Animals (Scientific Procedures) Act 1986, but the
Home Office had failed to implement key regulations. Following
Uncaged's attempted publication of this information in September
2000, Imutran and their parent company Novartis sought a permanent
injunction for breach of confidentiality and copyright.

The Home Office initially announced that such allegations would
be investigated with the assistance of a small independent scrutiny
team from the expert advisory body, the Animal Procedures Committee.
However, the Home Office reneged on this commitment and instead
launched an internal 'routine' review. Essentially,
the very persons criticised by Uncaged investigated their own conduct.

In 2002, further documents - including crucial project licences
and correspondence between Imutran and the Home Office - were leaked
from the Home Office. Interestingly, the Home Office declined the
opportunity to intervene in the case to prevent disclosure of its
confidential documents.

In 2003 the Defendants secured a historic legal victory that allowed
publication of over a thousand pages of confidential documents
which revealed matters of public interest, in particular the Home
Office's indulgent relationship with Imutran. Despite this
outcome, the Home Office has persisted with its refusal to establish
an independent inquiry into the affair. Lacking the financial resources
to initiate judicial review proceedings, Uncaged sought redress
through the Home Affairs Committee (HAC) and the PHSO. The HAC
decided not to conduct a full inquiry for various logistical reasons,
such as their existing workload.

Severity assessment and control

Many aspects of the PHSO report can be refuted. However, we believe
that the clearest and most salient aspect of Home Office maladministration - and
PHSO error - concerns the failure to adequately assess and control
primate pain and suffering caused by the procedures. This is perhaps
the most important aspect of the regulatory system and therefore
any such failures are particularly significant for adequate public
administration.

Uncaged explained to the PHSO that during the initial project
licence application for kidney xenotransplantation experiments
(which covered the majority of Imutran's xenotransplantation
research), Imutran and the Home Office deliberately underplayed
their severity in order to smooth through the approval of the application.

The experiments were classified as of 'moderate' severity
rather than the higher 'substantial' category: this
meant that the proposed experiments avoided examination by the
statutory Animal Procedures Committee (APC), which would have potentially
delayed or blocked the application at a time when Imutran were
determined to push ahead with the research as quickly as possible.

According to stated regulations, animal experiments are assessed
as 'moderate' when not a single animal is in danger
of suffering a 'major departure from their usual state of
health or well-being' or 'significant post-operative
suffering': such adverse effects are supposed to be categorised
as 'substantial' severity. One clear distinction between 'moderate' and 'substantial' severity
is that in 'substantial' experiments, the experiments
might continue until the animal dies.

Even before the kidney xenotransplantation experiments commenced,
Imutran and the Home Office must have known that the experiments
would have the potential to cause 'substantial' suffering
due to:

The highly invasive abdominal vivisection

complications likely
to arise from unconventional transplant surgery on relatively
small animals

the toxic effects of very high doses of experimental
immunosuppressive drug regimens

the effects of kidney rejection
over a number of days, causing nausea, vomiting, coma and death

Primates 'found dead'

In the event, in 'moderate' experiments at least seventeen
primates, such as Monkey X535f (see box right), were found dead
in their cages, and many more were allowed to deteriorate to a
collapsed state before they were finally euthanased.

The RSPCA report into this affair describes the adverse effects
endured by the primates - such as whole body shaking, grinding
of teeth, haemorrhaging, vomiting, weakness, wound-weeping, gangrene,
tremors and diarrhoea - as 'severe,... serious and very
unpleasant'. They go on to criticise the moderate severity
rating, arguing that a substantial rating was 'without doubt' necessary:
'to alert the scientists and technicians involved to the need for
greater vigilance, and in order to ensure a meaningful, realistic
and honest cost-benefit analysis'.

Thus, two issues of maladministration arise:

the initial severity
assessment was incorrect - partly because Imutran and the Home
Office failed to take proper account of the adverse effects of
drug poisoning in the licence application

the subsequent breaches of the moderate severity limit

The PHSO report (see particularly paragraphs 13-14) has rejected
this complaint on the basis of a fundamental misinterpretation
of the case and the regulations. In particular, the PHSO states
that death, in itself, is not considered to necessarily be a harm
to the animals and thus is not necessarily a breach of the moderate
severity limit. However, the PHSO's position is derived from
regulatory discussions concerning experiments performed under terminal
anaesthesia, where the animal is not conscious during any part
of the experiments and is killed before it comes round. This is
a fundamentally different situation to the Imutran experiments
where animals were allowed to suffer for several days until they
died. We clearly could not be saying that 'death in itself' was
the issue here given that we are pointing out that the animals
should have been euthanased earlier in the procedure.

We've consulted other experts in this policy area - former
members of the APC - who have stated that the PHSO's
position is 'totally surreal' and that we are 'absolutely
correct and they are completely wrong'.

We pointed out the PHSO's crucial mistake to them in our
request for a review of the complaint decision. However, the PHSO
refused to consider or respond to this point, eventually asserting
that it was merely an amplification of our original complaint and 'did
not raise new issues'. The PHSO's position is unsound:
our argument on this point was new as it responded specifically
to the key justification put forward in the PHSO report. We have
been left with the impression that the PHSO's priority has
been to dispose of the case and defend their original decision
rather than operate an open and fair review process.

1. Please note that this is a different case
to the xenotransplantation-related research currently licensed
by the Home Office that Uncaged is lobbying on.